- Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid
tumors that are not amenable for treatment with curative intent in adult patients
with: NSCLC, TNBC, HR+ breast cancer, recurrent platinum sensitive ovarian cancer, UC,
CRPC, and other advanced solid tumors with a BRCA or ATM gene defect
- Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available
from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor
biopsy during the screening period.
- Minimum age in Japan is 20 years.
- ECOG performance status 0 or 1.
- Resolved acute effects of prior therapy
- Adequate bone marrow, renal, and liver function.
- Negative serum pregnancy test at screening.
- Male and female patients able to have children must agree to use 2 effective methods
of contraception throughout the study and for up to 45 days for female patients and
105 days for male patients after the last dose.
- Signed and dated informed consent.
- Prior treatment with a PARP inhibitor.
- Prior immunotherapy with IL-2, IFN-?, or an anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CD137, OX 40, GITR, LAG 3, IDO, TDO,TIM 3, CTLA-4 antibody, or any other antibody
or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
Prior treatment with Sipuleucel-T for patients with mCRPC is allowed.
- Prior anti-cancer therapy within 4 weeks prior to study enrollment. Prior radiation
therapy within 2 weeks prior to enrollment. Prior palliative radiotherapy to
metastatic lesion(s) is permitted, provided it has been completed 2 days prior to
study enrollment and no clinically significant toxicities are expected (eg, mucositis,
- Major surgery within 4 weeks prior to study enrollment.
- Current use of immunosuppressive medication at the time of study enrollment.
- Known prior or suspected hypersensitivity to investigational products.
- Known history of immune mediated colitis, inflammatory bowel disease, pneumonitis,
- Active or prior autoimmune disease that might deteriorate when receiving an
- Prior organ transplantation including allogenic stem-cell transplantation.
- Vaccination within 4 weeks of study enrollment and while on trial is prohibited except
for administration of inactivated vaccines.
- Diagnosis of Myelodysplastic Syndrome.
- Patients with known brain metastases requiring steroids.
- Participation in other studies involving investigational drug(s) within 4 weeks prior
to study participation and/or during study participation.
- Persisting toxicity related to prior therapy >Grade 1
- Known HIV or AIDs-related illness.
- Positive HBV or HCV test indicating acute or chronic infection.
- Active infection requiring systemic therapy.
- Clinically significant cardiovascular disease: cerebral vascular accident/stroke or
myocardial infarction within 6 months prior to study entry; unstable angina,
congestive heart failure or a serious cardiac arrhythmia requiring medication.
- Current or anticipated use of a P glycoprotein (P gp) inhibitor (eg, dronedarone,
quinidine, ranolazine, itraconazole, ketoconazole), strong P gp inducer (eg, rifampin,
ritonavir, tipranavir), or strong inhibitor of breast cancer resistance protein (BCRP)
(eg, elacridar [GF120918]).
- Other acute or chronic medical or psychiatric conditions.